Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:52 PM
Ignite Modification Date: 2025-12-25 @ 5:27 PM
NCT ID: NCT04590404
Description: Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT04590404
Study Brief: Metabolism Informed Smoking Treatment: The MIST RCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MIST (Metabolism-Informed Smoking Treatment) All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT). 16 None 140 294 84 294 View
Guideline-Based Care All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results. 17 None 131 307 90 307 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anxiety (includes nervousness and panic attacks) SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emergency Medical Visit SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Emergency Medical Visit SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Medication Side Effects SYSTEMATIC_ASSESSMENT Product Issues None View
Scheduled Medical Procedure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Scheduled Medical Procedure SYSTEMATIC_ASSESSMENT Investigations None View
Scheduled Medical Procedure SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospital Admission SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT General disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospital Admission SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hospital Admission SYSTEMATIC_ASSESSMENT Investigations None View
Hospital Admission SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hospital Admission SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospital Admission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation and/or irritability SYSTEMATIC_ASSESSMENT General disorders None View
Anxiety (includes nervousness and panic attacks) SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View